It is recognized that numerous medical conditions exist in which it becomes necessary to gain percutaneous access to viscera such as the stomach or small intestines. Situations where a patient has lost the ability to swallow and will require long term nutritional support may dictate feeding directly into the stomach or jejunum. Feeding in this manner may be accomplished by inserting a feeding tube into the patient's stomach such that one end remains anchored in the stomach, while the other end remains external to the patient's body for connection to a nutrient source. Such feeding tubes may be inserted into a patient's stomach in a number of ways. For example, the feeding tubes may be endoscopically placed, surgically placed through an open incision, laparoscopically placed, or percutaneously placed under endoscopic, fluoroscopic or ultrasonic guidance. ifferent types of feeding tubes may be placed using these procedures, including gastrostomy, jejunostomy or gastro-jejunostomy tubes. These tubes may be retained in the lumen (stomach or intestine) with a variety of retention anchors. These anchoring mechanisms include: inflatable balloons, obturatable domes, fixed dome-type bumpers, or suture wings.
Prior to placing the actual enteral feeding device, it is generally necessary to perform a gastropexy procedure wherein the stomach wall is drawn against the abdominal wall at a location where the stoma tract will be eventually defined. This attachment is critical to prevent inadvertent separation and exposure of the peritoneal cavity to contamination and possible peritonitis.
Initial placement devices are often not readily removable without additional invasive procedures. That is, many initially placed anchoring devices contain rigid retention members that are not readily removable without additional procedures. These retention members are typically rigid T-shaped or H-shaped metal fasteners (collectively referred to as a “T-bar”) and are not removable, but are allowed to pass naturally in the patient's stool. In many cases, however, the T-bar is not passed and remains within the body cavity. Moreover, during the six to eight weeks it takes for the fistula's stoma tract to be established, the T-bar of the prior art gastropexy device may embed itself into the gastric or intestinal wall and ultimately lead to infection. Furthermore, the T-bar itself may have sharp edges which can be uncomfortable for the patient.
In many of these procedures, in order to achieve the desired seal between the stomach and the abdominal wall, a traction force must be applied to the anchoring mechanism. The force is applied in such a way as to pull the stomach cavity to the abdominal wall so that the penetration through both may heal together, resulting in the tissue layers essentially adhering to each other. It is necessary to apply this traction force for a period of a couple of days through a couple of weeks until the attachment forms and stoma site adequately heals. During this period the patient has reduced mobility which may lead to additional post-operative complications.
There is thus a need and desire for an improved tissue anchoring device that may be used during initial placement or creation of a stoma site. Such a device would foster the permanent fusion of the stomach wall to the abdomen. This would serve to reduce the invasiveness of the procedure, greatly enhance wound healing, and enable immediate, post-placement gastric access for feeding and drainage, and ultimately allow a traumatic exchange of the low profile device. What is needed is a fixation device that is easy to place within an internal body cavity, allows for the formation of a stoma between the internal body cavity and the external environment, and enables the user to easily remove the fixation device when it is no longer necessary.